"Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations" was a circular published by the federal Office of Management and Budget (OMB). It has been replaced by 2 CFR 200 OMB Uniform Guidance.
A pre-approved templatepdf logo[View Image] that can be used to streamline the negotiation process between institutions and industry, thereby enabling researchers to obtain protocols in a timely manner for evaluation of their inclusion as a site in potential industry-sponsored clinical trials.
Any untoward medical occurrence in a human subject participating in research. The event is undesirable and unintended, but unless the frequency or severity causes the event to be unanticipated, it is not necessarily reportable to the IRB. Adverse events include abnormal laboratory findings, a symptom or disease temporally associated with the use of an investigational agent, or the progression of disease, whether or not related to the medicinal (investigational) product. See also Unanticipated Problem.
Data that has been gathered, processed, and expressed in a summary or report form for reporting purposes, such as making comparisons, predicting trends, or other statistical analyses. Aggregate data is collected from multiple sources and/or measures, variables or individual human subjects. Because aggregate data is the consolidation of data from multiple sources, it is typically not able to be traced back to a specific human subject.
Those allowable costs that benefit the specific grant or contract to which they are being charged and are deemed reimbursable by the sponsor (2 CFR 200.405).
Those categories of costs that can be charged to a grant, such as salaries and equipment. Certain types of costs, such as the cost of alcoholic beverages, are not allowable and may not be charged to a contract or grant. To be allowable, the cost must be reasonable, allocable, consistently treated, and conforming to any limitations or exclusions of the agreement (2 CFR 200.403).
A law enforced by the U.S. Department of Agriculture to protect certain animals from inhumane treatment and neglect. The Animal Welfare Act is “the only Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and by dealers.”
Under federal law, the process that leads to a grant or cooperative agreement, as opposed to procurement. The purpose is to "assist" the grantee with activities or research it would have performed independently if it had the resources.
A formal examination of an organization's or individual's accounts, programs, site, or financial situation to ensure compliance with applicable laws, regulations, or agreements/contracts. VCU's annual audit by APA meets Uniform Guidance standards.
Identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects.
A gift of money or property made to an organization or person through a will or estate plan.
A procedure in which one or more participants and/or members of the research team are kept unaware of the assigned intervention. In single-blind studies, the subjects remain unaware of the assigned intervention. In double-blind studies, the subjects and investigators remain unaware of the assigned intervention. In triple-blind studies, investigators, subjects, and data analysts remain unaware of the assigned intervention.
Broad Agency Announcement (BAA)
An announcement of a federal agency's general research interests that invites proposals and specifies the general terms and conditions under which an award may be made. A Broad Agency Announcement is not considered a formal solicitation under FAR.
The detailed statement outlining estimated project costs to support work under a grant or contract.
The act of amending the budget by moving funds from one category or line item to another. Budget adjustments may require prior approval by the sponsor. See also Re-Budget.
The interval of time--usually twelve months--into which the project period is divided for budgetary and funding purposes.
A controlled substance, as received from the manufacturer or supplier, “to be used in, or capable of use in, or being used in, the manufacture of the same or other controlled or non-controlled substances in finished form.” (21 CFR 1304.22(a)(1)) Bulk form substances may be dispensed to authorized users for a single day. Unused bulk form substances must be returned to the registrant at the end of each day.
Per 45 CFR 160.1033, a person or entity who, on behalf of a covered entity, performs, or assists in performance of, a function or activity involving the use or disclosure of protected health information, such as data analysis, claims processing or administration, utilization review, and quality assurance reviews, or any other function or activity regulated by the HIPAA Administrative Simplification Rules, including the Privacy Rule. Business Associates are also persons or entities performing legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, or financial services to or for a covered entity where performing those services involves disclosure of protected health information by the covered entity or another business associate of the covered entity to that person or entity. Special attention should be paid to the term “on behalf of.” Academic institutions are rarely business associates since the term is not applicable to collaborative relationships.
Business Associate Agreement (BAA)
An agreement that contractually defines the rights and responsibilities between a covered entity and a business associate that would not otherwise be bound by HIPAA. A covered entity’s contract or other written arrangement with its business associate must contain the elements specified at 45 CFR 164.504(e)6.
A five-character ID number used extensively within the federal government, assigned by the Department of Defense’s Defense Logistics Agency (DLA). The CAGE code is used to support a variety of mechanized systems throughout the government and provides a standardized method of identifying a given legal entity at a specific location.
Unexpended funds from one budget period that are brought forward into the next budget period and are available for expenditure. Whether carryforward is allowable is contingent upon the sponsor terms and conditions.
Case Report Form (CRF)
The official clinical trial data recording document or tool for both sponsors and regulatory authorities. It may take the form of paper documents, electronic systems, or a combination of both.
A statement signed by an authorized representative of the University indicating that the University will adhere to certain conditions and will or will not undertake certain actions. Several certifications are required before receiving federal funds.
Effort shown on an effort report which has been certified by the employee or by a person with first-hand knowledge of the work performed. See the VCU Post-Award Financial Management Policy.
The number assigned to a federal program in the CFDA.
A written order signed by the contracting officer directing the contractor to make changes in the processes, goods, and/or services under a contract. The contract will have a changes clause that specifies the authority of the contracting officer to order such changes without the consent of the contractor.
An online training program that provides education about research ethics and integrity, compliance, and professional development. VCU fulfills the federal mandate to ensure all researchers and personnel involved in human subjects research are trained by requiring initial and continuing education through CITI. See VCU’s CITI Requirements page.
Research involving the use or access to information that has been classified as top secret, secret, or confidential as determined by the U.S. Government to prevent unauthorized disclosure for the protection of U.S. citizens, U.S. democratic institutions, homeland security, and U.S. interactions with foreign nations. VCU does not have a Facility Security Officer and does not perform Classified Research.
Refers to Virginia Commonwealth University Health System (VCUHS) Effort Reporting Categories including clinical practice and administration, supervision of interns and residents, VCUHS administration, and other educational and administrative activities. See the VCU Post-Award Financial Management Policypdf logo[View Image] .
According to the FDA, any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i), 507(d), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit (21 CFR 50.3). See the VCU Conduct of Human Subjects Research Policy.
Research with human subjects that is: 1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes (a) mechanisms of human disease; (b) therapeutic interventions; (c) clinical trials; and (d) development of new technologies. 2. Epidemiological and behavioral studies. 3. Outcomes research and health services research.
Clinical Research Associate (CRA)
Also called a clinical monitor or trial monitor, a health care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, including pharmaceutical companies, medical research institutes and government agencies.
Clinical Research Audit
A systematic, second-tier review of a research process or a specific research project by individuals not involved with the study to evaluate the performance of sponsors, investigators, research personnel, and monitors in the conduct of the study including all study-related activities and documents. Audits are typically conducted at clinical sites to determine compliance with regulations and adherence to guidelines, to verify the validity and integrity of clinical data submitted in applications for approval, and to assure that the rights and welfare of participants in clinical studies have been protected.
Clinical Research Coordinator/Clinical Research Nurse (CRC)
An electronic platform used by an institution to maintain and manage the planning, performance, and reporting functions, participant contact information, and deadlines/milestones of clinical trials. VCU’s CRMS is OnCore.
A clinical study involves research using human volunteers (also called subjects or participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.
A web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. This web site and database of clinical studies is commonly referred to as a "registry and results database." See VCU’s ClinicalTrials.gov Program.
The act of fulfilling all sponsor requirements and applicable internal procedures to terminate or complete a research project.
Having a permanent or temporary medical condition that affects mental processing or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. When seeking informed consent for a clinical research study, the Principal Investigator must make a specific determination as to cognitive impairment on a case-by-case basis.
The federal agency assigned to and responsible for negotiating a university's F&A rate and resolving audit questions. VCU's cognizant agency is DHHS Audit Agency.
The federal rule that governs most federally funded research conducted on living human subjects and that aims to ensure that the rights of human subjects are protected during the course of a research project. Historically, the Common Rule has focused on protection from physical and mental harm by stressing autonomy and consent.
Competing Interest (CI)
VCU ORIE’s designation for characterizing interests that reasonably appear to be related to the investigator’s institutional responsibilities and could appear to affect the design, conduct, or reporting of (primarily) human subjects research, depending on the context of the research. Although a CI generally pertains to financial interests that are less than $5,000 or 3 percent value, a CI could also be a nonfinancial interest. VCU deems CIs as warranting attention and internal management. See the VCU Conflict of Interest in Research Policypdf logo[View Image] .
A proposal that is submitted to a sponsor for the first time or an unfunded proposal that is re-submitted in order to vie for available research funds. An ongoing project must compete again if the term of the original award has expired.
Adherence to the requirements imposed, often by federal regulation, and the responsibilities institutions assume to meet those requirements. The institution signs certifications or representations regarding compliance for most proposals or awards. It is important that the institution have systems in place to ensure compliance and maintain adequate records to demonstrate compliance.
The primary method by which the OVPRI informs administrators, faculty, and staff of project-related systems, processes, and guidance for complying with project-related laws, regulations, and policies.
An agreement where one or more parties agrees to maintain confidential information received from one or more other parties. VCU wants such information to be clearly identified as proprietary and/or confidential and wants a time limit specified for maintaining confidentiality. Also sometimes referred to as a Non-Disclosure Agreement (NDA).
The state of restricting the dissemination of information, the definition may vary by field of use.
Conflict of Commitment
Paid or unpaid activities outside of the workplace that detract from an individual’s University responsibilities or that involve the Significant Use of University Resources that are dedicated to achieving VCU’s mission.
Conflict of Interest (COI)
A situation in which financial or non-financial interests of the investigator, or members of that person’s immediate family, compromise, or appear to compromise, an investigator’s professional judgment in exercising an institutional duty or responsibility, including the design, conduct, or reporting of research. A financial COI (FCOI) in research occurs when the investigator, or any member of that person’s immediate family, possesses a significant financial interest (SFI) that is, or appears to be, in conflict with the objectivity needed to fulfill the investigator’s University responsibilities. See VCU’s Conflict of Interest in Research Policypdf logo[View Image] .
Conflict of Interest in Research Committee (COIC)
A standing committee of the University composed of faculty, administrative personnel, and ex-officio members and convened with an appointed chair under the authority of the Vice President for Research and Innovation (VPRI). The COIC is charged with: evaluating investigators’ financial interest reports within the context of specific proposals and research protocols referred by the COI in Research Program; determining whether reported interests rise to the level of COI or CI; developing a resolution, including the recommendation of a management plan, as appropriate; problem solving about management plan adherence; and advising on COI policy and process issues. See VCU’s Conflict of Interest in Research Policypdf logo[View Image] .
Conflict of Interest (COI) Investigator
Designated by the Principal Investigator (PI) on proposals and on IRB and IACUC submissions. A COI Investigator is an individual, regardless of title, role, or position, who is responsible for the design, conduct, and/or reporting of research. Individuals with such research responsibilities may be, but are not limited to, senior/key personnel, sub/co-investigators, subrecipient investigators, medical investigators, collaborators, consultants, students, trainees, or research coordinators. Exceptions include students or personnel whose research activities are directly supervised. The term denotes individuals who must report their interests in the AIRS, so that these interests can be reviewed in the context of the research; it does not imply that they have a conflict of interest. See VCU’s Conflict of Interest in Research Policy.
Conflict of Interest (COI) in Research Program
Based in the Office of Research Integrity and Ethics: administers activities related to the AIRS, COI/CI assessment, dispositions, management, and COI consultation and education for the university research enterprise; reviews reported interests in the AIRS and other sources for information about COI or CI in the context of individual research projects (the COI in Research Program may contact COI Investigators with questions about reported interests and/or their relatedness to the given research project); makes expedited COI or CI dispositions, recommends referral to the COIC for full review, and implements management plans resulting from expedited or COIC review; and communicates with relevant individuals and/or entities about COI/CI management and oversees management plan adherence. See VCU’s Conflict of Interest in Research Policypdf logo[View Image] .
Consistently Treated Costs
Expenses that are treated alike when circumstances are alike, particularly as to whether similar expenses are categorized as either direct costs or as F&A/indirect costs.
An agreement between two or more institutions that allows collaborative work on a single project by investigators of the institutions. The pass-through entity receives an award from the sponsor that directs that a subaward or subcontract be issued to the subrecipient institution(s).
An agreement between an individual or organization (consultant) and the University whereby the consultant provides services of an advisory nature. The University may enter into an agreement of this type when the necessary expertise is not available within the University community. A VCU employee may not be paid as a consultant on one of VCU's sponsored programs; this principle applies at most universities. A VCU employee may not use significant University resources in conducting a consulting project.
Noncompliance characterized by any of the following:
Repeated noncompliance on a single project or across multiple projects by the same principal investigator or project team
A pattern of ongoing activities that indicates a lack of understanding of project requirements that may affect the validity of the project or the allowability of costs of the project
Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once a year. The criteria for approval are defined by federal regulations.
Continuation Project (Non-Competing)
Applicable to grants and cooperative agreements only. A project can be approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, a continuation award is made for the next budget period, subject to the availability of funds. Continuation projects do not compete with new project proposals and are not subjected to peer review after the initial project approval.
Generally, an agreement between two or more parties creating obligations that are enforceable. However, when working with the federal government, contract has a very specific meaning. A federal contract is distinct from federal assistance mechanisms (grants or cooperative agreements) because the federal government uses a procurement mechanism to provide the project funding. Federal contracts are governed by a strict set of terms and conditions, including clauses from the Federal Acquisition Regulation (FAR). These contracts usually require frequent reporting and a high level of accountability to the sponsor.
Contract Research Organization (CRO)
A company that provides clinical trial and other research support to the pharmaceutical, biotechnology, and medical device industries. A CRO is contracted by another company to manage and lead the company’s trials, duties, and functions.
Any substance listed in the Controlled Substances Act (21 CFR, part 1300 to end) or Title 54.1, Section 3400 of the Code of Virginia. Lists of Scheduling Actions, Controlled Substances, and Regulated Chemicals are published by the DEA.
Controlled Unclassified Information (CUI)
Information that requires safeguarding or dissemination controls pursuant to and consistent with regulations and policies created by individual government agencies. See the VCU Export Compliance and Research Security Policy.
Cooperative Research and Development Agreement (CRADA or CRDA)
Originally a mechanism to transfer technology between the government and a university. CRADAs can also be used to transfer equipment, supplies, or to pay travel expenses. A CRADA is often the only mechanism for transferring funds into a federal agency.
Co-Principal Investigator (Co-PI)
A senior investigator who may share responsibility for the conduct of a portion of the research or other activities described in a proposal or an award. Definition may vary by funding agency.
A form of protection provided by the laws of the United States (U.S. Copyright Statute, 17 U.S.C. Section 101) to “original works of Authorship” including literary, dramatic, musical, artistic and certain other intellectual works, whereby copyright owners may claim, for a limited time, certain exclusive rights to specified works. This protection is available to both published and unpublished works and gives the copyright owner the exclusive right to reproduce, distribute, sell, perform, display or prepare derivatives of the work, and to protect a copyright against infringement. Copyright protection does not extend to an idea, procedure, process, slogan, principle or discovery. See the VCU Intellectual Property Policy.
Used to place on record a verifiable account of the date and content of the work in question, so that in the event of a legal claim, or case of infringement or plagiarism, the copyright owner can produce a copy of the work from an official government source.
A set of federally mandated accounting standards used in determining costs on negotiated procurements. CAS is intended to ensure uniformity in budgeting and spending federal funds.
Cost of Living Allowance/COLA
Funding that may be granted to employees who are based away from their home location, to provide for a higher cost of living than at the home location. COLA is also used to represent Cost of Living Adjustment.
The portion of the costs of a sponsored project that is borne by the University. To qualify as cost sharing, a cost must be (1) verifiable from the University's records, (2) allocable as necessary and reasonable for proper and efficient accomplishment of the project objective, and (3) allowable under applicable cost principles and administrative regulations. Both mandatory and voluntary committed cost sharing must be adequately documented in the University's records. The University will make a cost sharing commitment only when required by the sponsor (mandatory) or when required by the competitive nature of the award, and then only to the extent necessary to meet the specific requirements of the sponsored project. Salary over cap does not technically meet the definition of cost share because it is unallowable.
A process to move or transfer payroll and non-payroll expenditures from one fund to a different fund source, or even within the same fund when correcting sub-object codes. VCU requires certain VCU Cost Transfer Procedures be followed to adhere to federal regulations.
An association of research universities, affiliated medical centers, and independent research institutes whose primary function is to advocate for policies and practices that fairly reflect the mutual interests and separate obligations of federal agencies and research institutions as it relates to research and graduate education.
Coverage analysis is the process of evaluating each clinical research study in order to determine if a clinical study qualifies for coverage of routine care costs in accordance with the requirements of Medicare and the U.S. Patient Protection and Affordable Care Act, document the appropriate responsible payer (i.e. third party payer or study sponsor) of each study related clinical service/item, and develop a comprehensive billing plan which supports compliance with essential reporting and clinical billing requirements throughout the conduct of a clinical study. See the VCU Coverage Analysis Procedures.
Covered Entity/Affiliated Covered Entity (ACE)
Per 45 CFR 160.103: A health plan, a health care clearinghouse, or a health care provider that transmits health information in electronic form in connection with a transaction for which the U.S. Department of Health and Human Services has adopted a standard. Note: This term is specific to data use agreements covering protected health information (PHI). An affiliated covered entity is a designation allowed per 45 CFR 164.105 (b)(1) when two or more legally separate covered entities designate themselves as a single covered entity. The VCU Health System and (parts of) VCU operate as an ACE. The following units are part of the ACE: VCU Health System (VCUHS) and all satellite clinics, School of Medicine, School of Pharmacy, School of Nursing, School of Dentistry, VCU Employee Health, VCU Telecommunications, VCU Audit & General Management, VCU Police Services, VCU Office of General Counsel, VCU Office of Research and Innovation.
An independent group that carries out important aspects of clinical trial monitoring, such as regular interim analyses of accumulating data, particularly in multi-site clinical trials where safety concerns may be unusually high.
Data & Safety Monitoring Plan (DSMP)
A specific plan developed by the local principal investigator (PI) that outlines how study progress will be monitored throughout the course of the research to ensure the safety of subjects as well as the integrity and confidentiality of data.
Unauthorized acquisition of data that compromises the security, confidentiality, or integrity of personal or other information maintained by an agency or institution.
Data at VCU is divided into three classifications by Technology Services: Category I, Category II, and Category III, with Category I data being the most sensitive. Security measures are detailed by Technology Services based on the category of data being utilized. The VCU Data Classification Tool can be utilized to determine the classification of data. See the VCU Data Classification Standardpdf logo[View Image] .
Data Coordinating Center
In a multi-site study, the center responsible for overall data management, monitoring and communication among all sites including general oversight of the conduct of a human subjects research project.
Data Use Agreement/Data Transfer and Use Agreement (DUA/DTUA)
A contractual agreement used to define how access to and/or exchanged data may be used. The primary consideration is the protection of protected health data (PHI) in accordance with HIPAA Regulations found at 45 CFR Part 160-164. However, DUAs can be used in other situations where the exchange of data is necessary. The DUA details permitted use(s) and disclosure of the data (primarily through publication of research results of the provided data); sets forth the data recipient’s responsibilities; establishes a period of time for the use of the provided data; and establishes conditions that would be considered to breach the agreement. A DUA should always be put in place when the data to be transferred is from human subjects and/or the data to be transferred is HIPAA protected. If the data to be provided is completely de-identified and there is no means to re-identify, a DUA is not needed. To meet this qualification, the data must be stripped of the data elements specified as personally identifiable information (PII). If the data contains any of these identifiers, then a DUA must be in place. DUA’s must also be in place if the research is supported by sponsored funds and there are data ownership and/or dissemination requirements.
A supplement to the FAR that includes clauses particular to DOD contract procurement.
Expenditures exceed funds available, also referred to as cost overrun. An excess of cost over budget. A cost overrun or deficit necessitates the removal of costs in the amount by which the actual cost exceeds the budget.
Documents the investigator’s entrustment of research project-specific responsibilities to individual members of a research team according to their qualifications, training, and/or licensure. Each member of the research team must sign and/or initial and date the DOA log or approved documentation to indicate their understanding and assignment of delegated tasks. The PI acknowledges the delegation of responsibility for each individual member of the research team by signing and/or initialing the DOA log or approved documentation.
A document used to track when and how an investigational device has been used throughout the life of a research project. A device accountability log should be maintained for any research project that uses study-supplied devices.
Costs that can be identified specifically with a particular sponsored program, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (2 CFR 200.413) See the VCU Post-Award Financial Management Policypdf logo[View Image] .
Disclosure Statement (DS-2)
An Institution of Higher Education (IHE) that receives aggregate federal awards totaling $50 million or more must disclose their cost accounting practices by filing a Disclosure Statement (DS-2). Changes to the DS-2 require the approval of the cognizant agency for indirect costs.
The term "dispense" means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term "dispenser" means a practitioner who so delivers a controlled substance to an ultimate user or research subject. (21 USC §802(10))
Relinquishment of contaminated, expired, excess, residual (or waste), or unwanted controlled substances.
Division of Animal Resources (DAR)
A division of the Office of Research and Innovation that provides a humane and high quality animal care and use program to facilitate research and teaching at VCU.
Transfer of equipment, money, goods, services, and property with or without specifications as to its use. Sometimes “donation” is used to designate contributions that are made with more specific intent than is usually the case with a gift, but the two terms are often used interchangeably.
No statutory authority exists for the drug-free work force requirements. Requirements are contained in DFAR, 252.223-7004. Drug-Free Work Force addresses employee involvement with controlled substances regardless of where such involvement takes place, random drug testing of employees, and other intrusive personnel policies. This clause is only applicable to DOD solicitations and contracts involving access to classified information or when the contracting officer decides inclusion is necessary. Universities have successfully negotiated out this compliance requirement for basic research contracts. Like the workplace certification, there is no requirement to flow-down these provisions to subrecipients. VCU has never accepted this clause.
The Drug-Free Workplace Act of 1988. This regulation stipulates that no federal funding will be available for institutions or individuals who do not have a drug-free workplace policy in place. VCU meets all requirements of this regulation. There is no requirement for flow down to subrecipients under either grants or contracts.
An item that has civil applications as well as terrorism and military or weapons of mass destruction (WMD)-related applications. The precise description of what is “subject to the EAR (Export Administration Regulations)” is in 15 CFR 734.3, which does not limit the EAR to controlling only dual-use items.
Dual Use Research
As defined by the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, “Research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that could be utilized for both benevolent and harmful purposes.” See the VCU Dual Use Research of Concern in the Life Sciences Policy.
Dual Use Research of Concern
As defined by the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, “Life Sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel [sic], or national security.” See the VCU Dual Use Research of Concern in the Life Sciences Policy.
Data Universal Numbering System, a system developed and regulated by Dun & Bradstreet (D&B) that assigns a unique numeric identifier to a single business entity. VCU’s DUNS number is 10-530-0446, and the DUNS+4 is 1053004460000.
Any portion of University effort toward a sponsored activity for which the sponsor pays salary/benefits.
Effort, Percent Effort
The proportion of time spent on any professional activity and expressed as a percentage of total time. Total effort for an employee always equals 100%, even if the appointment is less than full time. Effort is divided into three categories: sponsored, non-sponsored and clinical activities (if applicable, see clinical effort definition). Sponsored activity is funded by an external entity, such as a state agency or a private organization, and includes conducting or administratively supporting programs for research, instruction, or other purposes (such as training or public service). Non-sponsored activities include University-funded research as well as activities like instruction, departmental research, public service, and administration. See the VCU Post-Award Financial Management Policypdf logo[View Image] .
A vehicle used to assemble all the data from different electronic- and paper-based systems to capture and organize diverse data in a manner that satisfies the study protocol, and to enable the data to be systematically reviewed and analyzed.
Electronic Data Capture (EDC)
In a clinical trial, EDC offers data entry and storage functions via the internet for study site staff, monitoring by clinical research associates, identification of potential errors by data management personnel, and review of study status by project management personnel. It has built-in functions of validation and edit checks that ensure the accuracy of data collected in an efficient way. In addition, EDC has audit trails that record all data revised in the system.
Emergency Use Authorization (EUA)
A legal means for the Food and Drug Administration to approve new drugs or new indications for previously approved drugs during a declared emergency.
Someone directly employed by an organization who is legally empowered in writing to sign export license applications or other requests for approval on behalf of the organization. An empowered official has the independent authority to: 1) inquire into any aspect of a proposed export by the organization; 2) verify the legality of the transaction and the accuracy of the information contained in the application; and 3) refuse to sign any license application or other request for approval without prejudice or other adverse recourse
Funds that have been set aside or "claimed" for projected expenses pending actual expenditure of the funds. Typically, the issuance of a Purchase Order (PO) results in an encumbrance of the face value of the PO.
A fund usually in the form of an income-generating investment, established to provide long-term support for the institution, including for faculty/research positions (e.g., endowed chair).
Employer Identification Number (EIN)
The number the Internal Revenue Service assigns to every employer, also "Federal Identification Number" (FIN), which uniquely identifies that taxable entity. Use of this number enables a sponsor to identify the correct recipient to receive the funds awarded under a contract or grant. VCU's EIN is 54-6001758.
Someone directly employed by an organization who is legally empowered, in writing, to sign export license applications or other requests for approval of an export license on behalf of the organization. See the VCU Export Compliance and Research Security Policy.
An article of nonexpendable, tangible personal property having a useful life of more than one year and an acquisition cost that equals or exceeds $5000. If a single device is assembled from parts with a total cost of $5000 or more, it becomes "equipment."
As it applies to clinical trials, those documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced. These documents show the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.
Requirements that, when met, disqualify a person from participation in a clinical trial.
As it applies to informed consent documents, any written or verbal communication that waives, or provides the appearance of waiving, any legal rights of the participant or appears to release VCU, VCUHS, the investigator, or VCU/VCUHS staff from liability for negligence.
A limited number of actions that normally require awarding agency prior approval but for which a federal agency, and sometimes a non-federal agency, has waived its authority and given this authority to the grantee.
A review of minimal risk research involving human subjects by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
Expired Substances/Unusable Substances
Controlled substances for which the expiration date has passed. Or tablets, injections, liquid, or preparations compounded in error that contain controlled substances that can no longer be used for research due to contamination, etc.
An export occurs when an item is transferred physically from the U.S. to a foreign country, e.g., actual shipment of goods or goods carried during international travel, as well as when information is transmitted to a person or entity in a foreign country, whether in writing, or via email, phone, fax, internet, and verbal conversations. See the VCU Export Compliance and Research Security Policy.
Regulations governing the export, including deemed export and re-export of dual use commercial items and technologies and other commercial items and technologies without an obvious military use. These regulations are under the jurisdiction of the U.S. Department of Commerce. (15 CFR Parts 730-774). See the VCU Export Compliance and Research Security Policy.
Export Control Exemption and/or Exclusion
Specific, legally-recognized contexts in which export control regulations are inapplicable to the transmission of information, such as Fundamental Research, Public Domain/Publically available, Educational Information, and Disclosures to Bona-fide Full Time Employees (ITAR exemption only).
A written authorization provided by the appropriate governing regulatory authority of the U.S. government detailing the specific terms and conditions under which export or re-export of export controlled items is allowed.
Export License Exception/Exemption
An authorization that, under very specific conditions, allows for the export or re-export of items that would normally require an export license.
An additional period of time given by the sponsor to an organization for the completion of work on an approved grant or contract. An extension allows previously allocated funds to be spent after the original expiration date. Most federal agencies, including NSF and NIH allow an extension of the final period of up to one year by the institution with adequate notice to the sponsor on research grants only. (See also No Cost Time Extension)
Also referred to as indirect costs, those costs incurred in support of many activities and that cannot be identified with a single sponsored project. The cost of operating and maintaining buildings, use of equipment, general and departmental administrative expenses, sponsored projects’ administration, and library costs are usually considered F&A costs. These costs are essential in the support of sponsored program activities. In accordance with regulations and principles promulgated by the Federal Office of Management and Budget (“OMB”), institutions of higher education are permitted to recover F&A costs associated with supporting sponsored programs. See the VCU Facilities and Administrative Cost Recovery Policy.
Facilities and Administrative Costs Recoveries (FACR) Revenue
The University retains a portion of the Facilities and Administrative Costs Recoveries centrally and the remainder is allocated to the schools. The dean of each school or college determines the allocation of the school’s share. See the VCU Facilities and Administrative Cost Recovery Policy.
Federal Demonstration Partnership A cooperative initiative among 10 federal agencies and 154 institutional recipients of federal funds whose purpose is to reduce the administrative burdens associated with research grants and contracts.
Federal Acquisition Regulations (FAR)
The system established for the codification and publication of uniform policies and procedures for acquisition (i.e., federal procurement) by all executive agencies. In addition to the primary FAR document, there are agency acquisition regulations that implement or supplement the FAR.
Daily (business days) federal government publication of U.S. government procurement invitations, contract awards, subcontracting leads, sales of surplus property, and foreign business opportunities.
Federal Financial Report (FFR)
This standard form (SF) is used to report project expenditures on a time specific basis as indicated within the award agreement.
Federal Food, Drug and Cosmetic Act (1938)
Legislation passed in the United States in 1938 to specifically give authority to the Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. Under this legislation, manufacturers are required to test drugs for safety and present the evidence of safety testing to the FDA prior to marketing.
Federal Funding Accountability and Transparency Act (FFATA)
Federal Information Security Management Act of 2002 (FISMA)
A risk-based information security framework for resources that support federal operations and assets. VCU is subject to these terms when contractually obligated. See NIST Security Standards.
The official daily publication in the United States for federal rules, proposed rules, and notices of federal agencies and organizations, as well as executive orders and presidential documents.
Federalwide Assurance (FWA)
VCU maintains an active Federalwide Assurance (FWA) with the Department of Health and Human Services (FWA00005287). As stated in the FWA, VCU applies the federal regulations (45 CFR 46) to all human subjects research, regardless of funding. All research is guided by the ethical principles of the Belmont Report and is subject to equivalent protections.
Provides financial support to graduate students to pursue graduate studies without associated teaching or research responsibilities (as there are in a teaching or research assistantship). Fellowships are generally merit-based internal or external awards to support a medical resident or a student in a full-time course of study.
A controlled substance altered from bulk form (diluted, compounded, etc.) that will be used for research, i.e. bulk form diluted 1:10 becomes finished form. Finished form substances may be retained by authorized users until depleted.
Fiscal Year (FY)
Any twelve-month period for which annual accounts are kept. VCU's and the Commonwealth of Virginia FY is July 1 through June 30; the U.S. Government's FY is October 1 through September 30.
Fixed-Price (FP) Contract/Grant/Agreement
A contract/grant for which one party pays the other party a predetermined price for services rendered and that becomes due in full when deliverables are accepted. In some cases, Grants and Contracts Accounting’s ability to invoice is contingent upon the sponsor’s acceptance of the deliverables.
The Foreign Corrupt Practices Act of 1977 (amended 1988 and 1998) contains rules prohibiting bribery of foreign officials.
Any person who is not a U.S. citizen, or who is not a lawful permanent resident of the U.S. (i.e., not a green card holder), or who does not have refugee or asylum status in the U.S. This includes all foreign persons in the U.S. as tourists, students, businesspeople, scholars, researchers, technical experts, salespeople, military personnel, diplomats, etc. Any foreign corporation, business association, partnership, trust, society or any other foreign entity or group, any entity “effectively controlled” by a foreign entity, and/or any international organizations and foreign governments are considered “Foreign Person(s).”
Freedom of Information Act (FOIA)
A federal law that provides that citizens may request public documents in the possession of any federal agency. The federal agency interprets what is and is not available under FOIA. A proposal to an agency is not a public document until awarded. If sections of a proposal contain confidential or proprietary information that should not be revealed when the proposal results in an award, those sections/pages must be clearly marked and an accompanying memo/letter be sent listing those locations and specifying that the information is confidential/proprietary.
Employee benefits paid by the employer (e.g., FICA, worker's compensation, withholding tax, insurance, etc.). VCU’s current fringe benefit rate can be found on the University Controller’s Office website.
Research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community because there are no publication restrictions for proprietary or national security reasons.
Range of time during which proposals are accepted and reviewed, and funds are awarded. If a sponsor has standing proposal review committees (or boards) that meet at specified times during the year, application deadlines are set to correspond with those meetings. For some sponsors, if proposals are received too late to be considered in the current funding cycle, they may be held for the next review meeting.
The European Union directive designed to harmonize data privacy laws across Europe, to protect and empower all EU citizens’ data privacy, and to reshape the way organizations across the region approach data privacy.
Generally Accepted Accounting Principles (GAAP)
A common set of accounting principles, standards, and procedures that companies must follow when they compile their financial statements.
Awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available. The unique flexibility, or lack of restrictions, makes gifts attractive sources of support. See the VCU Sponsored Agreements and Gifts Policy.
An international, ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.
A set of principles intended to assure the quality and integrity of non-clinical laboratory studies that support research or marketing permits for products regulated by government agencies.
Also referred to as "applicable law," it is the law that controls an agreement or contract and that will be used in any dispute of said agreement or contract. VCU, as an instrumentality of the Commonwealth of Virginia, cannot accept a contract governed by the laws of another state or other jurisdiction.
A graduate student who receives formal instruction directly from a faculty member and who assists the faculty member with their course(s), research, or administrative endeavors. At VCU, graduate assistants are considered students, not employees.
A type of financial assistance awarded to an organization for the conduct of research or other program as specified in an approved proposal. A federal grant, as opposed to a federal cooperative agreement, is used whenever the awarding office anticipates no substantial programmatic involvement with the recipient during the performance of the activities. The PI of a research grant has significantly greater flexibility in making changes to the research plan than the PI of a research contract. As with any agreement, a grant has terms and conditions that must be followed. See the VCU Establishment of Sponsored Project Subcontracts and Subawards Policy.
A sponsor's designated individual who is officially responsible for the business management aspects of a particular grant, cooperative agreement, or contract. Serving as the counterpart to the authorized official or business officer of the grantee/contractor organization, the grant/contract officer is responsible for all business management matters associated with the review, negotiation, award, and administration of a grant or contract and interprets the associated administrative policies, regulations, and provisions. Also referred to as Contract Officer. For definition of scientific officer, see Program/Project Officer.
The internationally accepted primary reference on animal care and use. Its use is required in the United States by the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy).
“A public or private entity, including a billing service, repricing company, community health management information system or community health information system, and “value-added” networks and switches that either process or facilitate the processing of health information received from another entity in a nonstandard format or containing nonstandard data content into standard data elements or a standard transaction, or receive a standard transaction from another entity and process or facilitate the processing of health information into a nonstandard format or nonstandard data content for the receiving entity.” (See NIH HIPAA Privacy Rule: Information for Research)
Health Care Provider
A provider of services (as defined in section 1861(u) of the Act, 42 U.S.C. 1395x(u)), a provider of medical or health services (as defined in section 1861(s) of the Act, 42 U.S.C. 1395x(s)), and any other person or organization who furnishes, bills, or is paid for health care in the normal course of business.(See NIH HIPAA Privacy Rule: Information for Research)
Any information, whether oral or recorded in any form or medium, that (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.
A person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.
The primary source of information on research & development (R&D) expenditures at U.S. colleges and universities. The survey collects information on R&D expenditures by field of research and source of funds and also gathers information on types of research and expenses and headcounts of R&D personnel. The survey is an annual census of institutions that expended at least $150,000 in separately accounted for R&D in the fiscal year.
HIPAA Health Insurance Portability and Accountability Act
Any material of human origin including, but not limited to, blood, tissue, organs, urine, saliva, or any other cells or fluids.
Humanitarian Device Exemption (HDE)
An application to the FDA requesting approval to market a Humanitarian Use Device (HUD). The FDA approval process for an HDE does not have the same requirements as a drug or device. FDA approval of an HDE allows the applicant to market a HUD, subject to some profit and use restrictions. The HDE is usually held by the manufacturer of the HUD.
Humanitarian Use Device (HUD)
A “medical device intended to benefit patients in the treatment or diagnosis of a disease that affects or is manifested in fewer than 4,000 individuals in the United States per year” (21 CFR 814.3(n)).
Human Research Protection Program (HRPP)
VCU supports an HRPP to assure that the rights and welfare of human subjects are adequately protected in research. The VCU HRPP is established under the authority of the VCU Office of the Vice President for Research and Innovation.
An individual who is or becomes a participant in research, either as a recipient of an intervention or as a control, and/or an individual on whom an investigational drug or device is used. A subject may be either a healthy or unhealthy human. The Code of Federal Regulations (Section 102(f) of 45 CFR 46) defines "human subject" as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. See the VCU Conduct of Human Subjects Research Policy.
“A single legal entity that is a covered entity, performs business activities that include both covered and noncovered functions, and designates its health care components as provided in the Privacy Rule. If a covered entity is a hybrid entity, the Privacy Rule generally applies only to its designated health care components. However, non-health care components of a hybrid entity may be affected because the health care component is limited in how it can share PHI with the non-health care component. The covered entity also retains certain oversight, compliance, and enforcement responsibilities.” See the NIH HIPAA Privacy Rule: Information for Researchers.
Managed by the Chemical and Biosafety Section of the VCU Office of Safety and Risk Management, a committee that reviews proposed research or work to be conducted at or on behalf of the University that involves recombinant/synthetic DNA (rDNA). In addition to rDNA research, the IBC reviews and approves MUAs for research that is in compliance with NIH Guidelines, and that can safely be performed at VCU involving Select Agents; certain Human, Plant, and Animal Pathogens and Biological Toxins; Clinical trials involving any administration of rDNA and/or pathogens to human subjects; or other research projects conducted at or on behalf of the University which are deemed, by the Biosafety Office, to require IBC oversight.
A system that allows government grantees and contractors to report government-funded subject inventions, patents, and utilization data via the web to the government agency that issued the funding award. More than 30 U.S. federal funding agency offices use iEdison, consistent with the Bayh-Dole Act, its implementing regulations, and agency policies (including plant variety protection (PVP) reporting).
Project-specific contributions of a service or a product provided by an individual or organization where the cost is not tracked in the official VCU accounting system. Examples of in-kind contributions include equipment or labor. Volunteer hours are also considered to be in-kind contributions. Sponsors may have their own definitions of “in-kind” that differ from VCU’s definition. In those circumstances, the sponsors’ definition of “in-kind” governs the sponsored project. See the VCU Cost Sharing Policy.
A method of funding contracts that provides specific spending limits below the total estimated costs, usually with target dates. These limits may be exceeded only at the contractor's own risk. In essence, each increment is a funding action.
Indemnification, Hold Harmless
A clause that shifts the liability or loss from one party to another, usually without regard to fault (including undertaking any legal defense) for some legal action or claim for damages taken against the indemnified party. VCU is an instrumentality of the Commonwealth of Virginia. By direction of the Attorney General of the Commonwealth, VCU does not have the authority to indemnify or hold harmless any third party. We may instead offer insurance clauses.
In VCU’s Banner accounting system, a six-digit code created to serve as a shortcut that eliminates users having to enter all of the FOPAL (Fund, Organization, Program, Account, and Location) codes to retrieve financial data within Banner forms.
Indirect Cost Rate
The rate, expressed as a percentage of a base amount (MTDC for most awards/projects), established by negotiation with the cognizant federal agency on the basis of the institution's projected costs for the year, and distributed as prescribed in the Uniform Guidance.
Indirect Costs (IDC)
Costs related to expenses incurred in conducting or supporting research or other externally-funded activities but not directly attributable to a specific project. General categories of indirect costs include general administration (accounting, payroll, purchasing, etc.), sponsored project administration, plant operation and maintenance, library expenses, departmental administration expenses, depreciation or use allowance for buildings and equipment, and student administration and services. (See also Facilities and Administrative Costs.)
A general term for the communication process that is used by key research personnel to facilitate an individual’s informed choice about enrolling in a research project. During this process a participant voluntarily confirms his/her willingness to take part in research, after having been informed of all aspects of the research that are relevant to the participant’s decision to participate.
Informed Consent Form (ICF)
A document that provides appropriate information about a research study to allow a potential research subject to make an informed decision about participation.
VCU’s office tasked with commercializing University Inventions within the Office of Research and Innovation.
Institutional Animal Care and Use Committee (IACUC)
A committee set up within the University charged with the oversight of research with vertebrate animals and the facilities where that research occurs. Research protocols involving vertebrate animals must be reviewed and approved by the IACUC prior to initiation. Federal and some other sponsors require this approval prior to receipt of an award. An institution must provide an acceptable written assurance to the Office of Laboratory Animal Welfare at NIH that the institution is complying with the Animal Welfare Act, the Guide for the Care and Use of Laboratory Animals, and other applicable laws and regulations.
Institutional Base Salary (IBS)
As determined by University administrative procedures, the annual compensation rate for an employee’s University-related activities (see IBS compensation codespdf logo[View Image] currently included in the ECRT). IBS includes both compensation for university-related effort and compensation from the MCV Physicians (MCVP) Practice Plan for clinical effort. However, some specific types of compensation re not considered part of IBS and thus are not included for the purposes of effort reporting. These types include bonuses and reward/recognition compensation. This is consistent with 2 CFR 200.430(h)(2), which defines IBS as the annual compensation paid by an Institute of Higher Education for an individual’s appointment, whether that individual’s time is spent on research, instruction, administration, or other activities. Sometimes referred to as Institutional Salary. See the VCU Post-Award Financial Management Policypdf logo[View Image] .
Institutional Contact for Dual Use Research (ICDUR)
The individual designated by the University to be the institutional point of contact for questions relating to compliance with VCU’s Dual Use Research of Concern in the Life Sciences Policy and the liaison with the relevant USG funding agencies. The Senior Associate Vice President for Research Administration and Compliance will serve as VCU’s ICDUR.
Institutional Duties or Responsibilities
The professional responsibilities an investigator has by virtue of being a VCU employee, student, or trainee. These may include teaching, professional practice, service on committees, research, and research consultation. Institutional duties or responsibilities for subrecipient investigators refers to the work being done for VCU under the sub-award. See the VCU Conflict of Interest in Research Policypdf logo[View Image] .
An administrative body established to protect the rights and welfare of human research subjects who participate in research activities conducted under the auspices of the institution with whom it is affiliated or for whom it is acting. The IRB has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
Institutional Review Entity (IRE)
The committee established by VCU’s Dual Use Research of Concern in the Life Sciences Policy and the accompanying IRE Operating Procedures document. Membership is drawn from practicing scientists, safety and research experts, VCU’s attending veterinarian, and other experts, and meets on an as needed basis. The IRE is the final authority on the risk analysis of potential DURC, any relevant Risk Mitigation Plans, and any other bio-security review responsibilities as delineated in the IRE Operating Procedures.
A joint regulatory/industry project to improve, through harmonisation, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States, in order to make these products available to patients with a minimum of delay.
International Traffic in Arms Regulations (ITAR)
Regulations governing the exports and re-exports of items and services for military use, which include defense articles, including technical data, defense technologies, and defense services. These regulations are under the jurisdiction of the U.S. Department of State (22 CFR Parts 120-130). See the VCU Export Compliance and Research Security Policy.
Both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. See the VCU Conduct of Human Subjects Research Policy.
Any new and useful process, machine, composition of matter, life form, article of manufacture, software, or tangible property. See the VCU Intellectual Property Policy.
A comprehensive document summarizing the body of information about an investigational product obtained during a drug trial.
A medical device that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device. Devices may be new or modified, or there may be new intended uses of legally marketed devices.
A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well investigational drugs work and whether they are safe to use. An investigational drug may be approved by the FDA for use in one disease or condition but still be considered investigational in other diseases or conditions. Also called experimental drug, IND, investigational agent, and investigational new drug. (NCI Dictionary of Cancer Terms)
A University member who uses University facilities or resources to conduct research or a sponsored project. See Principal Investigator.
A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying institution, including an academic institution. Agreements are generally used to cover a single research study, categories of research studies, or research studies within a research program.
Any material, technology, equipment, technical data, software, source code, or commodity, and any information useful to, or used for, the development, production, or use of any material, technology, equipment, technical data, software, source code, or commodity.
Information that the NIH requests be sent after an application goes through initial peer review and is within the range of possible funding. NIH will need this information but does not require it with an application.
The NIH K awards are designed specifically for postdocs, trainees, and early career scientists who are interested in making the successful transition to an independent research career.
Individuals who are involved in the design and conduct of a research project including, but not limited to, principal investigators, co-investigators, sub-investigators, research coordinators, and any other research team member who has contact with research participants and/or participants’ research data and identifiers. Individuals whose primary contact with a research participant is in the context of clinical care but who offer no additional role in research are not considered key research personnel.
An individual, or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedures involved in the research. (45 CFR.46 102(c) and 21 CFR 50 3(l))
As defined by the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, a field of study that “pertains to living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, synthetic biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches for understanding life at the level of ecosystems, organisms, organs, tissues, cells, and molecules.” See the VCU Dual Use Research of Concern in the Life Sciences Policy.
Limitation of Cost
A mandatory clause for federal cost-reimbursement type contracts. Under the clause, the sponsor is not obligated to reimburse the contractor for costs in excess of the stated amount. The contractor, however, is not obligated to continue performance once expenses reach the stated amount. The Limitation of Cost clause can be routinely increased by contract modification in an incrementally funded contract.
Limited Data Set
See Data Classification Limited data sets exclude 16 of the 18 HIPAA identifiers, but allow for inclusion of the following: geographic information above the street level (e.g., city, state, zip code) and all dates or elements of dates (e.g., birth date, procedure date, admission date).
A method of exposing, sharing, or connecting data from different sources. In the health care context, personally identifiable information (PII) connected (linked) to certain health records that could compromise individual security must be either specifically protected or de-identified (e.g., the link must be broken). Linked data is sometimes used to describe data that was not previously linked but now is or may be linked by an identifying key or other method.
For grants exceeding $100,000, a lobbying certification (also known as the "Byrd Amendment") is required as confirmation that no appropriated funds were used or will be used to influence a federal employee or a member of Congress in connection with the award. If the award recipient has used non-appropriated funds to pay for lobbying activities by an individual not regularly employed by the recipient, an additional disclosure is required. Must be flowed down to subrecipients.
Cost sharing required by a sponsor as a condition of making an award. This requirement is always specified in the published description of the sponsor announcement. Although occasionally expressed as a fixed dollar amount, the requirement is usually expressed in terms of a percentage of the total project cost or a percentage of the sponsor share of the total project cost. Mandatory cost sharing expenses must be identified for cost accounting purposes and must be reported to the sponsor in the financial report of the project. Failure to document the agreed upon cost sharing during the course of the project will result in reduction of funds available from the sponsor. See the VCU Cost Sharing Policy.
A grant that requires a specified portion of the cost of a supported item of equipment or project be obtained from other sources as mandatory cost sharing. The required match may be more or less than the amount of the grant. Some matching grants require that the additional funds be obtained from sources outside the recipient organization. Some matching grants are paid in installments; the payments coincide with the attainment of pre-specified levels of additional funding. Matching grants are especially common in the sciences for large equipment grants and are standard practice in some government agencies.
Material Transfer Agreement (MTA)
A written agreement entered into by a provider and a recipient of research material. The purpose of the MTA is to protect the intellectual and other property rights of the provider while permitting research with the material to proceed. Generally speaking, an MTA is needed whenever there is a material transfer that is not covered by any other agreement (e.g., purchase order/procurement, grant award, or sponsored clinical trial). See VCU’s guidance about Material Transfer Agreements.
Mechanistic Clinical Trial
Studies designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.
Any health care product that does not achieve its primary intended purpose(s) by chemical action or by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids, such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions, such as pregnancy.
Medically Responsible Investigator
If research procedures involve clinical elements and the Principal Investigator is not qualified in the appropriate clinical area, does not hold an applicable license, or does not have privileges to practice where the research will occur, a licensed and institutionally credentialed clinician appropriately qualified by education, training, experience, and background with appropriate privileges must be designated as the Medically Responsible Investigator. The Medically Responsible Investigator must manage or delegate all clinical elements of the research, such as physical examinations, drug administrations, follow-up examinations, evaluation of lab values, test results, and review of all adverse events. Clinical elements of a study include any event, procedure, test or intervention that would require performance by a licensed/credentialed professional in a non-research setting.
Memorandum of Understanding/Memorandum of Agreement/Memorandum of Understanding Agreement (MOU/MOA/MUA)
An agreement between two (bilateral) or more (multilateral) parties. It expresses a convergence of will between the parties, indicating an intended common line of action. It is often used in cases where parties either do not imply a legal commitment or in situations where the parties cannot create a legally enforceable agreement.
A task that shows an important achievement in a project. A milestone should represent a clear sequence of events that incrementally build up until a project is complete.
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)). See the VCU Conduct of Human Subjects Research Policy.
An organization's stated purpose, which is designed to address a specified set of goals or problems. Almost all federal research agencies are designated as mission agencies.
An award document that modifies any aspect of an existing award. Examples: carryover approvals, adding or deleting special terms and conditions, changes in funding levels, NIH Minority Supplement, administrative changes initiated by the agency, extensions that include changes in terms, change of principal investigator, etc.
Modified Total Direct Costs (MTDC)
The widely used cost base for calculating F&A costs. MTDC is a subset of direct costs and excludes the following: equipment, patient care, tuition remission, off-campus space rental, alterations and renovations, scholarships and fellowships, and subaward costs in excess of the first $25,000.
In the context of clinical research, a visit performed to oversee the progress of a clinical research study and to ensure that the study is being conducted in accordance with the protocol and all regulations. These visits may be performed at the study site or remotely.
A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format “NCT” is followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
As identified in the VCU Federalwide Assurance (FWA), VCU relies on the NCI CIRB pediatric and adult panels to conduct IRB reviews on behalf of VCU (for NCI cooperative group research studies). This relationship is detailed in a written authorization agreement. NCI CIRB may be utilized for review of NCI cooperative group research studies.
Proposals that are submitted for the first time or ongoing projects that must recompete for funding prior to expiration of the original award.
An award not previously awarded, or a renewal or continuation award treated as a new award by the sponsor and given a new agency number. At VCU a new award necessitates a new grant ID and index number.
An extension of the period of performance beyond the original expiration date but with no additional funds, usually to allow the principal investigator to finish a project. Most federal agencies permit university approval to grant a one year NCTE to the final year of a research grant (not contract), so long as there is timely notification of the NCTE to the sponsor.
Failure on the part of the principal investigator or any member of the research team to comply with any of the following:
The terms of the sponsored agreement
Applicable laws or regulations
VCU policies or compliance notices related to the project
Non-Disclosure Agreement (NDA)
A contract by which one or more parties agree not to disclose confidential information that they have received from the other party as a necessary part of doing business together.
The legally binding document that serves as a notification to the recipient and others that a grant or cooperative agreement has been made. It contains or references all terms of the award and documents the obligation of funds.
Notice of Termination/Cancellation
A written notification that ends an agreement or contract with a set number of days of written notification.
In response to the medical experimentation conducted by Nazis during World War II, in 1947 the U.S. Military Tribunal in Nuremberg set forth a code of medical ethics for researchers conducting clinical trials. The code is designed to protect the safety and integrity of study participants.
A type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given). (NCI Dictionary of Cancer Terms)
U.S. Office of Foreign Assets Control The federal government office responsible for administering and enforcing foreign asset control regulations. This includes economic and trade sanctions against targeted foreign countries, terrorists, international narcotics traffickers, and those engaged in activities related to the proliferation of weapons of mass destruction. The regulations administered by OFAC include controls with regard to specific individuals, specific organizations, and certain countries. OFAC is under the U.S. Department of the Treasury. (31 CFR Parts 500-598).
A reduction to funding in a new budget year, typically by reducing the new budget year’s funding by the remaining unexpended balance of a previous year.
In February 2013, the U.S. Office of Science and Technology Policy (OSTP) issued a memorandum directing federal agencies with over $100M in annual R&D expenditures to develop plans to provide increased public (a/k/a “open”) access to the results of federally funded research. The OSTP policy requires that grant recipients whose research results are published in peer-reviewed journals submit the final, accepted manuscript of such articles to the federal granting agency or a designated repository. Articles are to be made freely, publicly available following an agency-determined embargo period, commonly twelve months. Other major outside funding sources, such as foundations, also support open access for their funded data generation in research.
Order of Precedence
A sequential hierarchy of nominal importance of contractual or regulatory documents.
Any service rendered by a faculty member to persons or organizations external to the university, without university sponsorship, for the purpose of advancing, applying, or transferring knowledge in a field of endeavor related to the faculty member's employment at the university. Such activity is beyond or in addition to the faculty member's university responsibilities; it generally occurs off-campus and requires only the time and special capabilities of the individual, without significant use of university facilities or supporting services. See VCU’s Intellectual Property Policy.
VCU Post Approval Monitoring and Quality Improvement Program The purpose of the program is to assist the University and investigators in conducting human research that is of the highest ethical quality and is compliant with federal, state, and local requirements. The PAMQuIP staff works towards this goal by improving investigator/IRB performance through monitoring, education and measurement of the overall quality, effectiveness, and efficiency of their research. In addition, the PAMQuIP staff acts as a resource for the VCU/HS research community by offering problem-solving tips, templates, focused educational services, external/internal audit preparation and referrals.
A non-federal entity that provides a subaward to a subrecipient to carry out part of a federal program. (2 CFR 200.74)
A government authority or license conferring a right or title for a set period, especially the sole right to exclude others from making, using, or selling an invention.
Using another's patent without adequate permission (usually a license).
A system using reviewers who are the professional equals of the principal investigator or program director who is to be responsible for directing or conducting the proposed project. It is a form of objective review. Peer review is legislatively mandated in some programs and in other programs is administratively required.
Data that relate to a living person who can be identified from the data and other information that could potentially identify that person. Examples of personal data include: information of a financial or medical nature, or the person's name, address, or social security number. If medical in nature, the information may need to be treated in accordance with HIPAA. When such data is used as research data, special protections must be in place to protect the individual's identity
Personally Identifiable Information (PII)
Any information maintained by an agency, including: (1) any information that can be used to distinguish or trace an individual’s identity, such as name, social security number, date and place of birth, mother’s maiden name, or biometric records; and (2) any other information that is linked or linkable to an individual, such as medical, educational, financial, and employment information. When allowing access to PII, care should be taken that the data or combination of data elements, when linked (i.e. taken in combination), do not allow the individual to be distinguished or traced.
Phases of Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions.
Phase 0 trials: Exploratory studies that often use only a few small doses of a new drug in a few patients.
Phase I trials: An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
Phase II trials: The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
Phase III trials: The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, and compare it with standard or equivalent treatments.
Phase IV trials: After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use.
U.S. Public Health Service, previously a major part of DHHS, but reorganized out of existence. It remains on paper primarily because of significant sets of regulations previously imposed under its name that remain in effect for the organizations that used to be under its authority.
Previously known as COS/Community of Science, a subscription web service that provides access to funding opportunities for research and that identifies researcher expertise from within or outside the University.
A harmless pill, medicine, or procedure that has no therapeutic effect.
An individual who comes to VCU for the purpose of engaging in advanced research training following receipt of a Ph.D. or appropriate first professional degree (e.g. M.D.). They primarily perform work requiring advanced knowledge in the fields of science and/or learning. Postdoctoral scholars are appointed on a full-time basis for fixed terms (typically of one year's duration each), not to exceed 5 years. See the VCU Postdoctoral Scholars Policy.
A brief description, usually 2-10 pages, of research plans and estimated budget that is sometimes submitted to determine the interest of a particular sponsor prior to submission of a formal proposal. Pre-proposals may be in the form of a letter of intent or brief abstract. Also termed Preliminary Proposal.
Pre-Study Site Visit (PSSV)
In clinical research, the visit is typically scheduled following the completion of a sponsor’s feasibility questionnaire. The purpose of the visit is to qualify the study site for participation and verify the institutional and research team capabilities to effectively and efficiently conduct and sustain the research project. The visit may include tours of the facility, verification of equipment and personnel availability and qualifications, recruitment planning and feasibility review, and interviews with key study personnel.
The individual with overall responsibility for the conduct of research or other activity described in a proposal, protocol, or an award, and/or the individual with fiduciary responsibility for award management.
A score derived from the rating given a research proposal by each member on a review committee. It is used to help determine which approved proposals will be granted awards based on funds available.
The control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others, including data, specimens, or information. For example, persons may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center clearly identified by signs on the front of the building. The evaluation of privacy also involves consideration of how the researcher accesses information from or about potential participants (e.g., recruitment process).
The IRB operating at VCU carries out the function of a privacy board for the purpose of ensuring privacy protections of health information used or created in the conduct of human subjects research.
Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) (45 CFR 46.102(f)). See the VCU Conduct of Human Subjects Research Policy.
Under federal law, the process that leads to a contract, as opposed to assistance. The purpose is to "procure" the contractor's goods and services to meet a governmental goal.
Describes the existence of a research opportunity. It may describe new or expanded interest in a particular extramural program or be a reminder of a continuing interest in an extramural program. Program announcements, especially federal, may contain specific information that becomes part of the award or specific deviations from the sponsor's normal mode of doing business.
A sponsor's designated individual officially responsible for the technical, scientific, or programmatic aspects of a particular grant, cooperative agreement, or contract. Serving as the counterpart to the principal investigator/project director of the grantee/contractor organization, the program/project officer deals with the grantee/contractor organization staff to assure programmatic progress. (For definition of business officer, see Grant/Contract Officer.)
Periodic, scheduled reports required by the sponsor summarizing research or project progress to date. Fiscal and invention reports may also be required.
Program Research and Development Announcement (PRDA)
An announcement and solicitation for proposals to conduct research, development and related activities in the energy field, frequently used by the U S. Department of Energy.
Project Period (PP)
The total time for which support of a project has been approved by a sponsor. A project period may consist of one or more budget periods. (See also Budget Period.)
A subset (record or transmission) of health information, including demographic information, collected from an individual. It is created or received by a health care provider, health plan, employer, or health care clearinghouse. It relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual. In addition, the information identifies the individual or can be used to identify the individual.
A document that describes the objective(s), design, methodology, statistical considerations, and organization of a study. The protocol usually also gives the background and rationale for the study, but these could be provided in other protocol-referenced documents.
Unintentional or accidental changes to or non-compliance with the research protocol that does not increase risk or decrease benefit; does not have a significant effect on the subject's rights, safety or welfare; and/or does not affect the integrity of the data. Sometimes deviations are noted as “Protocol Not Followed” or PNF occurrences. Deviations may result from the action of the subject, researcher, or research staff.
Protocol Review and Monitoring Committee (PRMC)
The VCU Massey Cancer Center scientific review committee, the Protocol Review and Monitoring Committee (PRMC), reviews all clinical research studies involving patients with cancer, families of cancer patients, or cancer patients' healthcare providers. In addition, it reviews research involving cancer screening, diagnosis, or prevention, and cancer related surveys (e.g., attitudes about risk, prevention and treatment) of the general population. The focus of the PRMC is on scientific merit, priorities, and progress of the study. PRMC review is required by NCI and must be approved prior to IRB submission at VCU. See the VCU Massey Cancer Center PRMC site for additional details.
Unintentional or accidental changes to the research protocol that harm subjects or others or that indicates subjects or others may be at increased risk of harm.
Information that is published and that is generally accessible or available to the public: 1) through sales at newsstands and bookstores; 2) through subscriptions which are available without restriction to any individual who desires to obtain or purchase the published information; 3) through second class mailing privileges granted by the U.S. Government; 4) at libraries open to the public or from which the public can obtain documents; 5) through patents available at any patent office; 6) through unlimited distribution at a conference, meeting, seminar, trade show or exhibition, generally accessible to the public, in the United States; 7) through public release (i.e., unlimited distribution) in any form (e.g., not necessarily in published form) after approval by the cognizant federal government department or agency; and 8) through fundamental research. (22 CFR 120.11)
A service of the U.S. National Library of Medicine that includes over 28 million citations from MEDLINE and other life science journals for biomedical articles back to the 1950s. PubMed includes links to full text articles and other related resources.
Managed by the Radiation Safety Section of the VCU Office of Safety and Risk Management and is mandated by the VCU/VCUHS Nuclear Regulatory Commission license. The charge of the RSC is to oversee use of licensed radioactive material and radiation-producing devices. The IRB requires documentation of RSC approval prior to IRB approval if the use of radiation is NOT for the subject’s direct clinical benefit.
RAMS-ACUP Research Administration Management System-Animal Care and Use Program
The Research Administration Management System used by VCU for the review and approval of animal research protocols.
RAMS-AIRS Research Administration Management System-Activity and Interest Reporting System
A secure Research Administration Management System (RAMS) for the reporting of confidential financial and non-financial interests and third party relationships. COI review and COI Committee (COIC) activities are managed via the AIRS. (Definition from VCU Conflicts of Interest in Research policy.)
RAMS-FORCE Research Administration Management System-Facilities Ordering Reporting Core Enterprise
The Research Administration Management System used by VCU for processing financial transactions with research cores.
RAMS-IRB Research Administration Management System-Institutional Review Board
The Research Administration Management System used by VCU for the review and approval of human subjects research.
RAMS-Reports Research Administration Management System-Reports
The Research Administration Management System used by VCU for grants financial and administrative management reporting.
RAMS-SPOT Research Administration Management System-Sponsored Programs Online Tracking
The electronic system implemented by the Office of Sponsored Programs used to manage the funding proposal and award process. RAMS-SPOT supports paperless routing and approval of all major sponsored project transactions, paperless record storage, budget capture, and in-system communications.
The process by which two or more alternative treatments are assigned to volunteers by chance rather than choice.
The action that a prudent person would have taken under the circumstances prevailing at the time.
The act of amending the budget by moving funds from one category or line item to another. (See also Budget Adjustment)
The process of presenting new information about the research to study participants that could affect their willingness to continue to participate in the research study. If the participant makes the decision to continue participating in the research study, a new informed consent form will be signed.
In the context of controlled substances, an individual assigned by the registrant to assist with the registrant’s records. The recordkeeper is not authorized to dispense substances, enter new substances into inventory, or dispose of substances. The recordkeeper provides only data entry services. The registrant is responsible for all actions and records of the recordkeeper.
The period of time a document(s) should be kept or retained, whether in electronic format or physical format. The record retention period usually depends on the record type and the business, legal and compliance requirements associated with the record. Record Retention periods may be established by both federal and state law. For more information, please visit VCU Records Management.
Occurs whenever any item or information is sent from one foreign country to another foreign country.
In the context of controlled substances, a full-time faculty member who holds a DEA or VBP registration and who is responsible for ordering, storing, using, recordkeeping, and disposing of controlled substances on his/her IACUC or VCU Controlled Substance Research protocols. Completion of appropriate training is required.
In the context of controlled substances, formal grant of specific authority for controlled substances activities by the DEA and by the VBP. Often referred to as a license or certificate.
An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.
The process of attempting to discern the identities that have been removed from de-identified data.
The document prepared when an investigator is leaving an institution and has institutional approval to take her/his sponsored project(s) with her/him to the new institution. The institution to whom the original award was made relinquishes its interests and rights to the original award to be transferred to another institution via the relinquishing statement.
Applicable to grants and cooperative agreements only. A competitively reviewed proposal requesting additional funds extending the scope of work beyond the current project period.
Representations and Certifications (Reps and Certs)
A list of statements of institutional policies, practices, and commitments that must be signed as part of some proposals. Always found in federal contract proposals. At VCU, OSP will fill them out or guide the PI in so doing.
Request for Applications (RFA)
Announcements that indicate the availability of funds for a topic of specific interest to a sponsor, generally contemplating the award of a grant rather than a contract. Specific grant announcements may be published in the Federal Register and/or specific sponsor publications. (See also Broad Agency Announcements.)
Request for Proposal (RFP)
Announcements that specify a topic of research, methods to be used, product to be delivered, and appropriate applicants sought. RFPs generally contemplate the award of a contract rather than a grant. Notices of federal RFPs are published in the Federal Business Opportunities.
Request for Quotations (RFQ)
Often used by industry to solicit proposals, a formal request to vendors for a price quotation on services, equipment or supplies to be purchased.
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Research may be defined in additional detail in certain contexts.
Research & Development (R&D)
A series of investigative activities to improve existing products and procedures or to lead to the development of new products and procedures.
Recorded information, regardless of form or the media on which it may be recorded, which constitute the original observations and methods of a study and the analyses of these original data that are necessary for reconstruction and evaluation of the report(s) of a study made by one or more investigators. Research data also includes all such recorded information gathered in anticipation of a report. Research data differ among disciplines. The term may include, but is not limited to, technical information, computer software, laboratory and other notebooks, printouts, worksheets, other media, survey, memoranda, evaluations, notes, databases, clinical case history records, study protocols, statistics, findings, conclusions, samples, physical collections, other supporting materials created or gathered in the course of the research, tangible research property, unique research resources such as synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA as well as genetic sequences and mapping information, crystallographic coordinates, plants, animals and spectroscopic data, and other compilations formed by selecting and assembling pre-existing materials in a unique way. The term does not include information incidental to research administration, such as financial, administrative, cost or pricing, or management information. See the VCU Corporate Research Agreements Policy.
Inaugurated in 2006, its members are Associate/Assistant Deans for Research or individuals who hold comparable responsibilities for research development within their respective College/School. Council members represent the research interests of each of the Schools and Colleges at VCU for their constituencies, and serve as a conduit of information from, and resource asset to, the Office of the Vice President for Research and Innovation (OVPRI). The Council meets regularly with the Vice President for Research and Innovation and the Associate Vice President for Research Development to address topics of specific interest to the VCU research enterprise and to identify resources and supports necessary for increasing the strength and competitiveness of VCU as a research university. See the VCU Corporate Research Agreements Policy.
The use of honest and verifiable methods in proposing, performing, and evaluating research; reporting research results with particular attention to adherence to rules, regulations, guidelines; and following commonly accepted professional codes or norms. (NIH What is Research Integrity?)
Research Integrity Officer (RIO)
Appointed by the Vice President for Research and Innovation (VPRI), the individual responsible for receiving and assessing allegations of research misconduct, assuring that there is a timely response to such allegations, ensuring the timely and thorough execution of relevant processes and proceedings, and disseminating communications to those involved in proceedings such as sponsors and agencies as well as those relevant to post-proceeding activities.
Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion.
Any recording of information, regardless of the means of recording, that relate to the conduct of research that is prepared, owned, used, received, or retained by an operating unit or employee of VCUHS or VCU. This includes all documentary materials recorded by any medium, transmitted by electronic mail or fax, and every other means or form of communication or representation.
Monies (or an accounting category for such funds) with specific requirements or restrictions as to use or disposition. Grants, contracts, and cooperative agreements are considered to be restricted funds, while gifts are usually considered unrestricted funds.
In the context of controlled substances, a person registered with the [Drug Enforcement] Administration as a Reverse Distributor. (21 CFR 1300.01)
University policy requires that the institution or PI retains the right to publish the results of a sponsored program, as it is part of our mission and obligation to disseminate knowledge and educate students. A short delay in publication for Intellectual Property protection, coordination with other publishers, or other good reason is allowed. Prohibition of the right to publish requires approval of the Vice President for Research and Innovation or delegate.
Payments made to employees of the institution for work performed.
Establishes a maximum annual rate of pay at which an individual can be compensated for full time effort over a twelve-month period. Salary charges to a contract, cooperative agreement, or grant from certain federal agencies cannot be paid at a monthly rate that exceeds 1/12th of the maximum annual rate of pay then in effect. NIH Salary Cap information
Salary Cap Cost Sharing
Cost sharing which occurs when the University proposes (or later assigns), effort by individuals whose salary exceeds a sponsor-imposed limit for individual salaries. It may not be offered for mandatory committed cost sharing. Salary cap cost sharing must be identified for cost accounting purposes. Under OMB definition, salary cap cost sharing is classified as voluntary committed cost sharing, but for ease of understanding, it is defined separately in University documentation. See the VCU Cost Sharing Policy.
An essential document for planning and conducting a federal audit of your organization. It also provides assurance to federal agencies that award financial assistance that their programs or grants were included in the audit.
Scientific Review Group
The NIH panel to which each grant proposal is sent for peer review. Formerly named Study Section.
Scope of Work (SOW)
The description of the work to be performed and completed on a research project or sponsored activity. A good SOW is very action oriented.
Any information that is protected from unauthorized access by an institution's policy. This information must be restricted to those with a legitimate business need for access. Examples of sensitive data may include, but are not limited to, some types of research data (such as research data that is personally identifiable or proprietary), public safety information, financial donor information, information concerning select agents, system access passwords, information security records, and information file encryption keys.
Serious Adverse Event (SAE)
Any adverse event whether or not related to the investigational product, which meets any one of the six criteria: a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, e) is a congenital anomaly/birth defect, or f) is an important medical event requiring medical or surgical intervention to prevent serious outcome.
Noncompliance characterized by any of the following:
Presents actual or potential increased risk to human subjects, animal subjects, the VCU community, or the public
Presents actual or potential risk of cost disallowances
Adversely affects the scientific integrity of the project
Significant Financial Interest (SFI)
A financial interest that reasonably appears to be related to the investigator’s institutional responsibilities and appears to directly and significantly affect the design, conduct, or reporting of research. SFIs include the following: Financial interest in a publicly traded entity (e.g. consulting fees or honoraria; equity interest including stock or stock options) that, individually or in aggregate, exceeds $5,000 in the 12 month period preceding COI review Any financial or ownership interest in a non-publicly traded entity (e.g. a start-up company) IP in which license-related payments have been received from an entity other than VCU. See VCU’s Conflicts of Interest in Research Policy.
Significant Risk Device (SR IDE)
A device that: is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; is for a use of substantial importance in diagnosing, curing, mitigating or treating disease, or preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. See the VCU Reporting Sponsor-Investigator IND or IDE Policy.
Significant Use of University Resources
Substantial and dedicated support of the University, including sponsored research, other grants received by the University, or materials subject to a material transfer agreement. Utilization of University laboratories or special instrumentation, dedicated services provided by University employees, special financial assistance or extensive use of shared facilities constitutes significant use. In contrast, the use of a computer in a faculty office, other commonly used equipment for teaching and learning activities, use of incidental supplies, and nominal use of University personnel or shared facilities are not considered significant use. See the VCU Intellectual Property Policy.
Federal award recipients that expend $750,000 or more in federal awards in a fiscal year are required to undergo a single audit, which is an audit of an entity’s financial statements and federal awards, or a program-specific audit, for the fiscal year.
Site Initiation Visit (SIV)
A meeting between sponsor representatives and study-site staff to ensure all clinical research study personnel staff for a given study are adequately trained, understand the protocol, and are well versed with the study-specific procedures before enrollment is initiated.
Small Business Innovation Research (SBIR)
Federal grant program created to provide support to small business concerns and investigators for research projects that have potential for commercialization. The SBIR program requires that the primary employment of the principal investigator for the grant be with the small business (over 50%). The small business concern may conduct the entire SBIR project without outside collaboration, or it may subaward some of the grant to a university.
Federal grant program created to provide support to small business concerns and investigators for research projects that have potential for commercialization. The STTR program allows (but does not require) that the principal investigator for the grant be primarily employed other than with the small business. The small business concern must subaward some of the grant to a university or other research institution because the goal of the program is to transfer technology developed at the small business.
Social, Behavioral, and Education Research (SBER)
Encompasses a range of methodologies and tackles questions that seek to improve our understanding of human behavior, attitudes, beliefs, and interactions as well as social and economic systems, organizations, and institutions.
A special type of award, often limited to a beginning researcher. Typically, such an award may be obtained for only one year.
Special Terms and Conditions
Terms and conditions of an award that are specific only to that individual award.
The organization that funds a sponsored program received by the institution. If VCU receives a subaward, the sponsor is the organization issuing that subaward. However, VCU may need to know if the subaward is issued under a federal award in order to comply with federal regulations.
An externally funded program under which the University is obligated to perform a defined scope of work according to specific terms and conditions and within budgetary limitations. These programs are to be budgeted and accounted for separately from other institutional activities. Sponsored programs include grants, contracts, cooperative agreements, clinical trial agreements, Intergovernmental Personnel Agreements and other awarding instruments supporting research, instruction, public service, and clinical trials. See the VCU Minimum Effort for Principal Investigators and Key Personnel on Sponsored Programs Policy.
According to the FDA in 21 CFR 312.3, an individual who both initiates and conducts an investigation and under whose immediate direction the investigational drug or device is administered or dispensed. If an investigator submits an IDE or IND to the FDA and is the PI, then the investigator is a SI and is responsible for the overall regulatory compliance (scientific, technical, financial, and regulatory) of the research study. The responsibilities are the same should a study be filed under another Sponsor’s IND. In both situations, the SI is responsible for complying with requirements of both investigator and sponsor (plans, designs, conducts, monitors, manages data, prepares reports, oversees regulatory and ethical issues, and published manuscripts).
A set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations.
Statement of Work (SOW)
The description of the work to be performed and completed on a research project or sponsored activity. A good statement of work is action oriented and could be used for any type of funding instrument.
Per the Code of Virginia State and Local Government Conflict of Interests Act, VCU employees are prohibited from having a personal interest in a contract with VCU, excluding their employment contract, unless an exception applies and is approved.
A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training. Expressly, this is NOT an employer-employee relationship. Stipends may NOT be paid from any other type of grant although students may be employed on them. A stipend does not generate fringe benefits, although health insurance is often an allowable cost to a fellowship or training grant.
An external, non-federal, third party performing substantive programmatic efforts under a subagreement.
Assessment made by a pass-through entity as to whether a third party is performing on a Sponsored Project as a collaborator (i.e., subrecipient) or a Contractor (i.e., Procurement). This process is required by 2 CFR 200 when federal funds are involved. The result of the process may impact the timing of the release of the subagreement.
An activity that refers to the pass-through entity’s ongoing responsibility to evaluate the performance of any and all subrecipients.
Subrecipient Monitoring Activities
Various elements of subrecipient performance must be monitored throughout the subagreement period of performance by the Pass-through Entity. These activities normally occur throughout the year and may include reviewing financial and performance reports submitted by the subrecipient; performing site visits at the subrecipient’s place of business to review financial and programmatic records and to observe operations; and engaging in regular communication with the subrecipient to evaluate the status of program activities and progress toward stated aims.
Subrecipient Risk Assessment
The pass-through entity’s process of evaluating a subrecipient’s risk factors to discern its ability to complete the proposed statement of work and comply with terms and conditions of the subagreement. The result of the subrecipient risk assessment process may impact the timing of the release of the subagreement
Subrecipient Risk Factors
Indicators of a subrecipient’s ability to successfully complete the proposed Statement of Work and comply with terms and conditions of the subagreement.
High-risk characteristics include but are not limited to: demonstrated weaknesses in administering federal funding; history of failing to adhere to applicable provisions of contracts and grant agreements, or weak internal control structures; an absence of low-risk factors; and other information as available, including status as a start-up with limited resources or with a paucity of prior experience in performing research and/or other sponsored activities.
Low-risk characteristics include but are not limited to: an active SAM.gov registration; a DUNS number; a negotiated rate agreement or consistent use of de minimis rate; sophisticated accounting and Procurement systems; requirement for single audit as defined in 2 CFR 200.501 or amended; and a conflict of interest policy that is compliant with sponsor regulations.
Supplemental (Re-budgeting or Modification) Proposal
A request to the sponsor for additional funds for an ongoing project during the previously approved performance period. A supplemental proposal may result from increased costs, modifications in design, or a desire to add a closely related component to the ongoing project.
Suspension and Debarment
Prohibition on an individual, institution or corporation receiving some benefit. As a result of Executive Order 12549 in 1986, an institution must certify, for receipt of a federal contract of grant, that it is not suspended or debarred by any federal department or agency.
A legally binding document authorizing work and appropriating funds as a supplement to a basic agreement. Task orders are subject to the terms and conditions of the original contract and may occasionally contain additional special terms applicable only to the specific task.
An agreement between two or more parties to participate in an activity. Commonly a teaming agreement is sought by a commercial entity to jointly propose a federal contract that requires the University's expertise for some portion of the work. VCU can only enter into an exclusive teaming arrangement when the agreement specifies an individual PI. The commercial entity must understand that VCU may team with another organization using another PI to work on similar research. A Consortium Agreement serves the same purpose between VCU and another institution for joint application under a grant.
Recorded information, regardless of form, of a scientific or technical nature. Often referred to as the "science" of a proposal.
A report prepared by the PI to inform a sponsor of the progress on a project the sponsor has funded. Submitting a technical report is often a requirement of the acceptance of an award for research.
Technology Control Plan (TCP)
The formalization of the processes and procedures the University project personnel will use to ensure that any subject items and information are not disclosed to unauthorized personnel or otherwise exported without the necessary U.S. government authorization. See the VCU Export Compliance and Research Security Policy.
Terms and Conditions of Award
All legal requirements imposed on an agreement by the sponsor, whether by statute, regulation(s), or terms in the award document. The terms of an agreement may include both standard and special provisions that are considered necessary to protect the sponsor's interests. All applicable terms must be included in the award document; however, frequently, terms are included only by reference.
Any drug (including a biological product) for human use, medical device for human use, human food additive, color, adaptive, electronic product, or any other article subject to regulation under the jurisdiction of the FDA.
Total Costs, Total Project Costs
The total allowable direct and indirect costs incurred by the institution to carry out an approved sponsored project or activity.
Information, including a formula, pattern, compilation, program device, method, technique, or process, that: (i) derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use; and (ii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy. VCU does not accept trade secrets. See the VCU Corporate Research Agreements Policy.
An occurrence during the conduct of a clinical research protocol that meets all of the following criteria: was not anticipated or foreseen, involves risk or harm to participants or others, AND, in the judgment of the investigator, was probably or definitely related to, or caused by, the research activity.
Any portion of University effort devoted to a sponsored activity that is above the amount committed in the proposal and the subsequent award. This “extra” effort is neither pledged explicitly in the proposal nor included in the award documentation as a formal commitment.
The Office of Management and Budget’s (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, commonly called “Uniform Guidance,” was officially implemented in December 2014. The Uniform Guidance, a “government-wide framework for grants management,” is an authoritative set of rules and requirements for federal awards that synthesizes and supersedes guidance from earlier OMB circulars. Uniform Guidance was drawn from OMB Circulars A-21, A-87, A-102, and A-133, and the guidance in Circular A-50 on Single Audit Act follow-up. (2 CFR 200)
Primarily federal grants, unilateral awards generally contain standard terms and conditions that do not require negotiation.
Many federal agencies have delegated to the institution the authority to exercise certain prior approvals required for federal research grants through the expanded authorities designation. These include, but are not limited to, carryover of unobligated balances and up to 12-month no-cost extension to the final budget period.
Any person engaged, participating in, or directly or indirectly supervising a university research-related activity, including but not limited to a full- or part-time faculty or staff member; VCU official; students assistant, student, fellow, or trainee; visiting faculty member or researcher; volunteer; agent of VCU or the VCU Health System; or, when covered by a sponsored program agreement or other contractual arrangement, a contractor, subcontractor, subawardee, or their respective employees. One is not a University Party when acting in a purely private role that in no way or manner implicates the University, unless the activity results in a report in which the individual is identified as having a university affiliation.
Include but are not limited to facilities, personnel, equipment, confidential information, supplies, and time designated to perform tasks and obligations in the scope of University employment. Funds and facilities provided by governmental, commercial, industrial, or other private organizations which are administered and controlled by the University shall be considered University resources for purposes of the VCU Intellectual Property policy.
Funding unspent or uncommitted at the completion of a budget or project period. The difference between the amount authorized by the award and the amount obligated by VCU (i.e., the amount unspent).
Monies (or an accounting category for such funds) with no requirements or restrictions as to use or disposition. Grants, contracts, and cooperative agreements are considered to be restricted funds. Gift are usually considered unrestricted funds.
In the context of controlled substances, a document completed by each registrant and authorized user tracking usage of controlled substances. The registrant must keep Controlled Substances Usage Logs for a minimum of two (2) years from the date of the last transaction.
The official source for spending data for the U.S. Government. Its mission is to show the American public what the federal government spends every year and how it spends the money. It provides a mechanism to track the money from congressional appropriations to the federal agencies and down to local communities and businesses.
Except as otherwise specifically provided by law, all public records shall be open to inspection and copying by any citizens of the Commonwealth during the regular office hours of the custodian of such records. The Code of VA (2015) explicitly excludes from FOIA-access the results of the study or research at state institutions of higher learning until such results have been publicly released, published, copyrighted or patented.
VCU Affiliated Covered Entity (VCU ACE)
VCU and VCUHS are jointly covered by HIPAA regulations under what is termed the VCU Affiliated Covered Entity (VCU ACE). All of the units included in the VCU ACE may have access to Protected Health Information during the course of standard business operations.
Virginia Board of Pharmacy (VBP)
The regulatory board under the Department of Health Professions with “authority to license and regulate the dispensing of controlled substances by practitioners of the healing arts.” (§ 54.1-3304.1.)
An individual who possesses a Ph.D. or its equivalent, and whose primary purpose at VCU is to conduct independent research, teach, or lecture on a topic he/she is valued for.
Voluntary Committed Cost Sharing
Cost sharing the University may offer in a proposal to reflect accurately the total resources necessary to complete a project or to make a proposal competitive. This offer is included in the award directly or by incorporation. Voluntary committed cost sharing expenses must be properly identified for cost accounting purposes, but generally are not included on financial reports to sponsors. See the VCU Cost Sharing Policy.
Voluntary Uncommitted Cost Sharing
Cost sharing that is not committed or budgeted for in a sponsored agreement. It need not be tracked for cost accounting purposes or reported to the sponsor, and if it arises from faculty or other personnel effort, it is excluded from separate identification in effort reporting. Voluntary uncommitted cost sharing most commonly results from a cost overrun on a project, or from researchers’ effort which is over and above that committed and budgeted for in a sponsored agreement. See the VCU Cost Sharing Policy.
An individual who observes, assists in, or conducts sponsored project or research activities on behalf of the University and who does not receive any academic credit or monetary compensation for these activities.
Generally, include the economically disadvantaged, racial and ethnic minorities, pregnant women, the uninsured, low income children, the elderly, the homeless, those with human immunodeficiency virus (HIV), prisoners and those with other chronic health conditions, including mental illness.
The documentation that a researcher, IRB, or Privacy Board provides to a covered entity showing that the IRB or Privacy Board has waived or altered the Privacy Rule’s requirement that an individual must authorize a covered entity's use or disclosure of the individual’s protected health information for research purposes.
An ongoing commitment to a certain promise. While the University may warrant, for example, that it is eligible to receive government funding, it cannot and should not warrant things it cannot control.
A fully accredited, independent commercial institutional review board that conducts reviews based on FDA regulations and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines. As identified in the VCU Federalwide Assurance (FWA), VCU relies on WIRB to conduct IRB reviews on behalf of VCU. This relationship is detailed in a written authorization agreement. WIRB is primarily used for the review of industry-sponsored human research, but may be utilized for other research at the discretion of the HRPP.